Low Oxygen Exposure and Weight Status
Pennington Biomedical Research Center · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05289310
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22–65 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 60
- US sites recruiting
- 1
- Study start
- May 16, 2023
- Record last updated
- July 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The objective of the proposed double-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance (intake and expenditure), and measure modulators of energy balance, following 8 wk of calorie restriction (-500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% FiO2, \~2640 m) or normoxia (8 h/night, 21% FiO2), using a commercially available, in-home tent system, in adults with obesity.
Being studied: Normobaric hypoxia (NH); Normobaric normoxia (NN)
Conditions: Obesity
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Obese (BMI between 30-39.9 kg/m2)
- Born at altitudes below 2,100 meters (\~7,000 feet)
- Currently residing in Tallahassee, Florida or surrounding area
- Completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
- Not taking any medication(s) that interfere with oxygen delivery/transport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers and/or any medication that depresses ventilation, diuretics, alpha and beta blockers).
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study.
- Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks
- Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.
Exclusion Criteria
- Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
- Individuals who have not completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
- Cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with oxygen delivery/transport (e.g., kidney disease, cardiovascular disease, etc.)
- Oxygen saturation \< 95% while awake or oxygen saturation dips below 88% for a total of ≥ 10 min overnight in normoxic conditions
- Evidence of apnea or other sleeping disorders
- Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
- Diagnosis or family history of sickle cell anemia/trait
- Hematocrit \<42% for males, \<36% for females
- Hemoglobin \<13 g/dL for males, \<12 g/dL for females
- Blood donation within 8 weeks of beginning the study
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 mo.
- Weight gain or loss > 10% of body weight during the past 6 months
- Adults unable to consent
Recruiting US locations
Pennington Biomedical Research Center
Baton Rouge, LA 70808
Site contact: Claire E Berryman, PhD,RD · claire.berryman@pbrc.edu
Study contacts (from the official record)
- Claire E. Berryman, PhD, RD · 3042161050 · claire.berryman@pbrc.edu
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